LUYE PHARMA's Innovative Drug LY03017 Enrolls First Patient in Chinese Phase II Trial for Alzheimer's Disease Psychosis

Stock News
Apr 15

LUYE PHARMA has announced that the first patient has been enrolled in a Phase II clinical trial in China for its self-developed innovative drug, LY03017, which is intended for the treatment of psychotic disorders associated with Alzheimer's disease. LY03017 is a new-generation 5-HT2A receptor inverse agonist and 5-HT2C receptor antagonist. Its target indications include treating psychotic symptoms in Alzheimer's disease, Parkinson's disease psychosis, and negative symptoms of schizophrenia. The company has a long-standing focus on the central nervous system therapeutic area, and LY03017 represents another new molecular entity being developed concurrently for both the Chinese and U.S. markets. The ongoing Phase II trial in China is a randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the preliminary efficacy and safety of LY03017 in managing hallucinations and delusions related to Alzheimer's disease psychosis. Previously, the drug also received approval to commence clinical trials in the United States. The company plans to accelerate the Phase II clinical development of LY03017 to further demonstrate its therapeutic benefits, with the goal of addressing significant unmet patient needs as soon as possible. The central nervous system therapeutic area is one of the company's core strategic focuses. It has built a portfolio of products with differentiated advantages covering various conditions such as depression, schizophrenia, bipolar disorder, and Alzheimer's disease. These include Erzofri® (paliperidone palmitate extended-release suspension) and Rykindo® (risperidone extended-release microsphere injection), which are approved in the U.S., as well as rivastigmine transdermal patch (twice weekly) approved in several European countries, Japan, and China, and Ruoxinlin® (toluradine venlafaxine hydrochloride extended-release tablet) approved in China. In addition, the company is actively advancing the development of next-generation innovative drugs, with several other new molecular entities in clinical stages, including LY03015, a dual-target VMAT2/Sigma-1R drug; LY03020, a dual-target TAAR1/5-HT2CR drug; and LY03021, a triple-target GABAAR/NET/DAT drug.

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